MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SEAL (4.5MM), 5-PACK; CLAMP, VASCULAR

Model Number HST III SEAL (4.5MM), 5-PACK

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm), 5-pack, they loaded the seal and inserted it into the aorta, but it was not properly deployed and they decided that it could not be used properly and gave up using it.Central anastomosis was performed with another device.There was no effect on the patient.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Device discarded: (4115/ 3221) despite request and/ or customer indicated that the device was discarded; however, the actual device involved in the adverse event had been already discarded and thus irretrievably lost for testing.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period jun-2019 through may-2021 was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

• Brand Name: HSK III SEAL (4.5MM), 5-PACK
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 12023892
• MDR Text Key: 261779797
• Report Number: 2242352-2021-00481
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: 00607567700307
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25156894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Patient Sequence Number: 1